ES2428010T3 - Pharmaceutical composition containing microcolloidal silver and carboxymethyl-beta-glucan for the disinfection of nasal mucous membranes - Google Patents

Pharmaceutical composition containing microcolloidal silver and carboxymethyl-beta-glucan for the disinfection of nasal mucous membranes Download PDF

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Publication number
ES2428010T3
ES2428010T3 ES10711743T ES10711743T ES2428010T3 ES 2428010 T3 ES2428010 T3 ES 2428010T3 ES 10711743 T ES10711743 T ES 10711743T ES 10711743 T ES10711743 T ES 10711743T ES 2428010 T3 ES2428010 T3 ES 2428010T3
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Prior art keywords
pharmaceutical composition
composition according
silver
disinfection
glucan
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ES10711743T
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Spanish (es)
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Luigi Mercuri
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DMG Italia SRL
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DMG Italia SRL
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/38Silver; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

Composición farmacéutica para la desinfección de las mucosas nasales, caracterizada porque contiene plata micronizada coloidal con carboximetil-ß-glucano, y al menos un conservante, y posiblemente al menos un aromatizante natural.Pharmaceutical composition for the disinfection of nasal mucous membranes, characterized in that it contains micronized colloidal silver with carboxymethyl-β-glucan, and at least one preservative, and possibly at least one natural flavoring.

Description

DESCRIPCION� Composición farmacéutica que contiene plata microcoloidal y carboximetil--glucano para la desinfección de las DESCRIPTION� Pharmaceutical composition containing microcolloidal silver and carboxymethyl - glucan for the disinfection of

mucosas nasales. nasal mucous membranes

La presente invención se refiere a una composición farmacéutica que contiene una cantidad adecuada de plata microcoloidal y de carboximetil--glucano para su uso en la desinfección de las mucosas nasales, según la reivindicación 1. The present invention relates to a pharmaceutical composition containing a suitable amount of microcolloidal silver and carboxymethyl glucan for use in the disinfection of nasal mucous membranes according to claim 1.

Las propiedades terapéuticas de la plata ya eran conocidas en la antigua Grecia: es un hecho conocido que las infecciones eran menos frecuentes en familias que utilizaban cubiertos de plata para comer. The therapeutic properties of silver were already known in ancient Greece: it is a known fact that infections were less frequent in families who used silverware to eat.

La plata presenta importantes propiedades antimicrobianas, ya que la presencia de una parte en 100 millones de plata elemental en solución es suficiente para obtener una eficaz acción antimicrobiana. Se conoce que los iones o radicales libres de la plata son un principio activo antimicrobiano. Silver has important antimicrobial properties, since the presence of one part in 100 million elemental silver in solution is sufficient to obtain an effective antimicrobial action. It is known that ions or free radicals of silver are an active antimicrobial principle.

Para conseguir que la plata sea hidrosoluble, es preciso utilizar su forma coloidal (una suspensión en agua de partículas de plata extremadamente finas), que se obtuvo por primera vez en 1920, mediante un proceso de hidrólisis en el que se utilizan dos electrodos de plata pura, sumergidos en agua desmineralizada o destilada, a los que se aplica una diferencia de potencial. To make the water soluble, it is necessary to use its colloidal form (a suspension in water of extremely fine silver particles), which was first obtained in 1920, through a hydrolysis process in which two silver electrodes are used pure, submerged in demineralized or distilled water, to which a potential difference is applied.

Antes del descubrimiento de los antibióticos en 1938, la plata coloidal obtenida de este modo (cuya denominación más apropiada debería ser plata iónica-coloidal), se recetaba en abundancia para una gran variedad de enfermedades e infecciones: de hecho, se había demostrado su eficacia frente a más de 650 patógenos diferentes. Before the discovery of antibiotics in 1938, colloidal silver obtained in this way (whose most appropriate denomination should be ionic-colloidal silver), was prescribed in abundance for a wide variety of diseases and infections: in fact, its efficacy had been demonstrated against more than 650 different pathogens.

De hecho, la plata coloidal permite una mejora en la función del sistema inmunitario ya que actúa como catalizador, desactivando las enzimas concretas necesarias para el metabolismo de diversas especies bacterianas, fúngicas y víricas. In fact, colloidal silver allows an improvement in the function of the immune system as it acts as a catalyst, deactivating the specific enzymes necessary for the metabolism of various bacterial, fungal and viral species.

La concentración ideal de plata coloidal es de entre 5 y 20 ppm, ya que una concentración superior podría provocar que las partículas en suspensión se volvieran a unir, aunque fueran del tamaño óptimo de 0,05 μm, provocando así una menor capacidad de absorción celular por parte del organismo. The ideal concentration of colloidal silver is between 5 and 20 ppm, since a higher concentration could cause the suspended particles to rejoin, even if they were of the optimum size of 0.05 μm, thus causing a lower cell absorption capacity by the body.

El interés en la plata se detuvo con el descubrimiento de los antibióticos, pero a partir de los años setenta del siglo XX se volvió a considerar su uso, sobretodo como antiséptico en el tratamiento de quemaduras. The interest in silver stopped with the discovery of antibiotics, but from the seventies of the twentieth century its use was considered again, especially as an antiseptic in the treatment of burns.

Dicho éxito es debido al hecho de que es un antiséptico seguro; de hecho, cuando la plata se utiliza en forma coloidal, los tejidos la absorben muy lentamente para no provocar efectos tóxicos. Por tanto, se puede ingerir por vía oral, y llegar a formar parte de aquellas preparaciones que tanto adultos como niños pueden ingerir a diario sin riesgo de sufrir ningún tipo de intolerancia, aunque se trate de un uso prolongado. Such success is due to the fact that it is a safe antiseptic; in fact, when silver is used colloidally, the tissues absorb it very slowly so as not to cause toxic effects. Therefore, it can be taken orally, and become part of those preparations that both adults and children can ingest daily without risk of suffering any type of intolerance, even if it is a prolonged use.

La plata coloidal se utiliza principalmente como antiséptico en dermatología para el tratamiento de ciertos tipos de lesión. Se conoce asimismo su aplicación como agente potabilizador de agua y como conservante en la industria de la cosmética, pero, debido a su elevado coste de producción, su uso es muy limitado. Colloidal silver is mainly used as an antiseptic in dermatology for the treatment of certain types of lesions. Its application is also known as a water purification agent and as a preservative in the cosmetics industry, but, due to its high production cost, its use is very limited.

En el campo de la otorrinolaringología, el conocido efecto antimicrobiano de la plata se ha utilizado extensamente para producir diversas composiciones farmacéuticas. In the field of otolaryngology, the known antimicrobial effect of silver has been widely used to produce various pharmaceutical compositions.

La solicitud de patente US nº. 2008/0020060 revela composiciones farmacéuticas que comprenden una suspensión coloidal de nanopartículas de plata elemental para su administración en forma de espray en las mucosas nasales de un paciente para controlar y tratar la rinitis. US Patent Application No. 2008/0020060 discloses pharmaceutical compositions comprising a colloidal suspension of elemental silver nanoparticles for administration as a spray in the nasal mucous membranes of a patient to control and treat rhinitis.

La patente US nº. 6.454.754 describe unos medios y un protocolo para tratar la infección de las vías respiratorias del paciente. El dispositivo objetivo de la presente invención es un nebulizador o unos medios de espray para producir una nebulización de gotículas de un tamaño apropiado, de un fluido que comprende un coloide de plata pura. Según los inventores, dicha administración de coloide de plata iónica permite un tratamiento más eficaz de una infección con una cantidad de agente antimicrobiano 10.000 veces inferior a la de las técnicas recetadas habitualmente. El uso de una composición terapéutica con base de plata, con aplicación en el campo de la medicina, para prevenir, tratar o reducir la velocidad de propagación o transmisión de bacterias, infecciones y similares, es el objeto de la solicitud de patente US nº. 2006/122082 para producir una espuma líquida o formulaciones en espray y/o gel. US Patent No. 6,454,754 describes a means and a protocol for treating the patient's respiratory tract infection. The objective device of the present invention is a nebulizer or spray means for producing a nebulization of droplets of an appropriate size, of a fluid comprising a pure silver colloid. According to the inventors, said administration of ionic silver colloid allows a more effective treatment of an infection with an amount of antimicrobial agent 10,000 times lower than that of commonly prescribed techniques. The use of a therapeutic composition based on silver, with application in the field of medicine, to prevent, treat or reduce the rate of spread or transmission of bacteria, infections and the like, is the subject of US Patent Application No. 2006/122082 to produce a liquid foam or spray and / or gel formulations.

Llegados a este punto es necesario diferenciar entre la plata metálica y la plata en forma de sales. At this point it is necessary to differentiate between metallic silver and silver in the form of salts.

Estas últimas poseen una acción terapéutica pero se caracterizan por una elevada toxicidad; de hecho, los tejidos las absorben con facilidad, lo que puede causar irritación. Además, pueden provocar el fenómeno de la acumulación, con la aparición de un color azulado en la piel, un proceso patológico conocido como quot;argiriaquot;. The latter have a therapeutic action but are characterized by high toxicity; In fact, tissues absorb them easily, which can cause irritation. In addition, they can cause the phenomenon of accumulation, with the appearance of a bluish color in the skin, a pathological process known as `` argiriaquot ;.

Claims (7)

REIVINDICACIONES 1. Composición farmacéutica para la desinfección de las mucosas nasales, caracterizada�porque contiene plata 1. Pharmaceutical composition for the disinfection of nasal mucous membranes, characterized in that it contains silver micronizada coloidal con carboximetil--glucano, y al menos un conservante, y posiblemente al menos un 5 aromatizante natural. Colloidal micronized with carboxymethyl-glucan, and at least one preservative, and possibly at least one natural flavoring. 2. Composición según la reivindicación 1, caracterizada� orque contiene plata micronizada coloidal en una cantidad comprendida entre 10 y 100 ppm para un total de 1000 g de composición, preferentemente 50 ppm. 2. Composition according to claim 1, characterized in that orc contains colloidal micronized silver in an amount between 10 and 100 ppm for a total of 1000 g of composition, preferably 50 ppm. 10 3. Composición según cualquiera de las reivindicaciones 1 o 2, caracterizada�porque contiene carboximetil-glucano en una cantidad de entre 0,1 y 5 g para un total de 1000 g de composición, preferentemente 1 g. Composition according to any one of claims 1 or 2, characterized in that it contains carboxymethyl glucan in an amount of between 0.1 and 5 g for a total of 1000 g of composition, preferably 1 g. 4. Composición farmacéutica según cualquiera de las reivindicaciones 1 a 3, en la que la plata coloidal se microniza 4. Pharmaceutical composition according to any one of claims 1 to 3, wherein the colloidal silver is micronized en forma de partículas con un diámetro comprendido entre 85 nm y 150 nm, y la mayoría de partículas tienen un 15 diámetro comprendido entre 92 y 121 nm. in the form of particles with a diameter between 85 nm and 150 nm, and most particles have a diameter between 92 and 121 nm. 5. Composición farmacéutica según cualquiera de las reivindicaciones 1 a 4, en la que se utiliza sorbato potásico y/o imidazil urea como conservante, cada uno en una cantidad comprendida entre 0,1 y 5 g por 1000 g de composición, preferentemente 1 g. 5. Pharmaceutical composition according to any of claims 1 to 4, wherein potassium sorbate and / or imidazyl urea is used as a preservative, each in an amount between 0.1 and 5 g per 1000 g of composition, preferably 1 g . 6. Composición farmacéutica según cualquiera de las reivindicaciones 1 a 5, en la que se utiliza al menos un aromatizante natural, y cada aromatizante natural se encuentra en una cantidad comprendida entre 0,1 y 5 g por 1000 g de composición, preferentemente 1 g. 6. Pharmaceutical composition according to any one of claims 1 to 5, wherein at least one natural flavoring is used, and each natural flavoring is in an amount comprised between 0.1 and 5 g per 1000 g of composition, preferably 1 g . 25 7. Composición farmacéutica según cualquiera de las reivindicaciones 1 a 6, caracterizada�porque se encuentra en la forma técnica de gotas para la desinfección de las fosas intranasales. Pharmaceutical composition according to any one of claims 1 to 6, characterized in that it is in the technical form of drops for the disinfection of intranasal pits. 8. Composición farmacéutica según cualquiera de las reivindicaciones 1 a 6, caracterizada�porque se encuentra en 8. Pharmaceutical composition according to any of claims 1 to 6, characterized in that it is in la forma técnica de espray para la desinfección de las fosas nasales. 30 the technical form of spray for the disinfection of the nostrils. 30 9. Composición farmacéutica según cualquiera de las reivindicaciones anteriores, en forma de gotas nasales que comprenden: 9. Pharmaceutical composition according to any of the preceding claims, in the form of nasal drops comprising:
ComponentesComponents
Cantidad  Quantity
Plata microcoloidal Carboximetil--glucano Sorbato potásico Imidazolidina urea Aromatizante natural Agua purificada Microcolloidal silver Carboxymethyl - glucan Potassium sorbate Imidazolidine urea Natural flavoring Purified water
50 ppm 1 g 1 g 1 g 1 g Hasta alcanzar 1000 g 50 ppm 1 g 1 g 1 g 1 g Up to 1000 g
35 10. Composición farmacéutica según cualquiera de las reivindicaciones 1 a 9 para su uso en la desinfección de las mucosas nasales, concretamente para niños de hasta doce años de edad. 10. Pharmaceutical composition according to any one of claims 1 to 9 for use in the disinfection of nasal mucous membranes, specifically for children up to twelve years of age. REFERENCIAS�CI�ADAS �EN�LA �DESCRIPCION  REFERENCES����������Description Esta lista de referencias citadas por el solicitante se proporciona únicamente para la comodidad del lector. No forma parte del documento de patente Europea. Aunque las referencias se han recopilado cuidadosamente, no se pueden 5 excluir errores u omisiones y la OEP declina toda responsabilidad en este sentido. This list of references cited by the applicant is provided solely for the convenience of the reader. It is not part of the European patent document. Although references have been carefully collected, errors or omissions cannot be excluded and the EPO declines all responsibility in this regard. Documentos�de�patentes�citados�en�aa�descripcion  Documents�paced� mentioned�in�aa�description · US 20080020060 A · US 2006122082 A 10 · US 6454754 · US 20080020060 A · US 2006122082 A 10 · US 6454754 Bibaiografia�no�reaacionada�con�aas�patentes�citadas�en�aa�descripcion  Bibliography, not an area activated, with patents mentioned in the description · KUBALA�et aa. Carbohydrate Research., 2003, vol.15 338, 2835-2840 KUBALA�et aa. Carbohydrate Research., 2003, vol.15 338, 2835-2840
ES10711743T 2009-02-20 2010-02-19 Pharmaceutical composition containing microcolloidal silver and carboxymethyl-beta-glucan for the disinfection of nasal mucous membranes Active ES2428010T3 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
ITRM2009A000077A IT1393272B1 (en) 2009-02-20 2009-02-20 PHARMACEUTICAL COMPOSITION CONTAINING MICROCOLLOIDAL SILVER AND CARBOSSIMETHYLBETHAGLAN FOR DISINFECTION OF NASAL MUCOSA AND ITS PREPARATION PROCEDURE
ITRM20090077 2009-02-20
PCT/IT2010/000064 WO2010095158A1 (en) 2009-02-20 2010-02-19 Pharmaceutical composition containing microcolloidal silver and carboxymethyl beta glucan for disinfection of the nasal mucosae, and process for preparation thereof

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ES2428010T3 true ES2428010T3 (en) 2013-11-05

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EP (1) EP2398458B8 (en)
ES (1) ES2428010T3 (en)
IT (1) IT1393272B1 (en)
WO (1) WO2010095158A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA118192C2 (en) 2015-10-22 2018-12-10 Юрій Захарович Толчеєв ANTI-VIRUS PHARMACEUTICAL COMPOSITION

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6500165B1 (en) * 1998-10-29 2002-12-31 Steven R. Frank Active antisepsis device
US20060122082A1 (en) * 2000-02-17 2006-06-08 Leonard Paul Foam/spray producing compositions and dispensing system therefor
US20080020060A1 (en) * 2006-07-21 2008-01-24 Williamson Robert R Process for treating rhinitis

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EP2398458B1 (en) 2013-07-17
ITRM20090077A1 (en) 2010-08-21
IT1393272B1 (en) 2012-04-12
EP2398458B8 (en) 2013-10-30
WO2010095158A8 (en) 2010-12-23
WO2010095158A1 (en) 2010-08-26
EP2398458A1 (en) 2011-12-28

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